D-0029-2018 Class II Terminated
FDA drug recall D-0029-2018 was initiated by Becton Dickinson & Company on September 15, 2017 and is designated Class II. Reason for recall: Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange) The recall status is terminated (terminated June 27, 2018). Affected quantity: 628,000 applicators.
Recall Details
- Product Type
- Drugs
- Report Date
- November 1, 2017
- Initiation Date
- September 15, 2017
- Termination Date
- June 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 628,000 applicators
Product Description
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
Reason for Recall
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Distribution Pattern
IL, MO, PA, TN, & VA
Code Information
Lot 7096622, exp 3/21/2020